Temporary Use of a Continuous Glucose Monitoring System as an Adjunct to Lifestyle Medicine Education for People With Type 2 Diabetes: a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Blood glucose profile
研究概览
简要总结
This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in a lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
详细描述
Glucose peaks after eating are an indication of the level of insulin resistance and the severity of disease in patients with T2DM. Many lifestyle factors affect the glucose elevation, including the glycemic index of food, timing of eating, physical activity, stress and sleep.
In practice, a glycemic profile, consisting of multiple glucose measurements before and after meals throughout the day, has sometimes been helpful in educating patients concerning the effects of their eating habits on blood sugar levels.
Would temporary use (8-10 weeks) of a continuous glucose monitoring system (CGMs) be a useful adjunct during lifestyle education in patients with T2DM or PD?
The purpose of this feasibility study is to evaluate the effectiveness of a CGMs on a small sample of patients while they are enrolled in a lifestyle medicine class, to:
- identify any logistical issue involved
- verify that useful data can be obtained for analysis
- inform development of a larger controlled study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be able to read and write English.
- •be enrolled in The Lifestyle Medicine Clinic, taught by Dr. Drozek
- •be diagnosed with type 2 diabetes (T2DM) or prediabetes (PDM)
- •be at least 18 years of age
- •be comfortable wearing a sensor continuously for up to 10 weeks
- •have a smart phone and be comfortable utilizing apps
- •be able and willing to daily enter data concerning food consumed, exercise, stress management activities and sleep.
- •be willing to complete a daily reflection on the relationship of their blood sugar to lifestyle activities.
- •be willing to complete a survey at the completion of the project about their perceptions of utilizing continuous glucose monitoring (CGM)
排除标准
- 未提供
研究组 & 干预措施
Pilot
Eligible subjects who have consented to the study, and have had the baseline data gathered as part of their participation in the Lifestyle Medicine Clinic, an intensive therapeutic lifestyle medicine program, will be given a CGMs device and supplies, and instructed in how to utilize these. They will set up the app on their smart phone to provide them with feedback on their glucose level to correlate with their lifestyle activities.
干预措施: Temporary Continuous Glucose Monitoring System (Device)
结局指标
主要结局
Blood glucose profile
时间窗: 12 weeks
The blood glucose profile will be evaluated for out of range values
次要结局
- participant survey(12 weeks)
研究者
David Drozek
Associate Professor
Ohio University